Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

Pharmacokinetics Clinical Trial

Official title:

An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072604
• Other study ID #: 14558
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2010
• Last updated: April 18, 2014
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs)

• Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor

• Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

• Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

Exclusion Criteria:

• History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products

• Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing

• Syndromes of asthma, rhinitis or nasal polyps

• Females who are pregnant or lactating

• Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment

• Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Acetylsalicylic acid (Aspirin, BAY1019036)
One oral dose of new formula Aspirin Prototype 1 under fasting conditions
• Acetylsalicylic acid (Aspirin, BAY1019036)
One oral dose of new formula Aspirin Prototype 2 under fasting conditions
• Acetylsalicylic acid (Aspirin, BAYE4465)
One oral dose of Aspirin Plain Tablet under fasting conditions
• Acetylsalicylic acid (Aspirin, BAYE4465)
One oral dose of Aspirin Dry Granules under fasting conditions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects		24 hours	No
Secondary	To assess safety and tolerability of the new aspirin formula		24 hours	Yes
Secondary	To assess additional pharmacokinetic parameters		24 hours	No

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